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Assistant Manager, Quality Assurance
5 months ago
**ABOUT THE COMPANY**
New Beta Innovation Canada Limited (NBI-CA) is a biopharmaceutical manufacturer of hemoglobin-based therapeutics. In Burnaby, BC, we have a state-of-the-art Good Manufacturing Practice (GMP) compliant facility, with custom-designed equipment for commercial-scale production. Our production processes are undergoing validation for rigorous GMP requirements.
Our operations include a full in-house analytical laboratory, a water purification plant, a skilled engineering team, and experts in compliance and regulatory affairs. These teams work collaboratively to ensure the safety and quality of both our processes and product. With headquarters in Hong Kong, NBI has a global presence in Canada and New Zealand.
We are a committed and innovative team who are passionate about doing great work to make a positive impact on animal health. We are always on the look-out for creative and passionate people who are eager to contribute to a bigger purpose.
**POSITION OVERVIEW**
Reporting to the Senior Manager, Quality Assurance & Validation, the incumbent will be responsible for managing QMS activities including change control, CAPA, deviation, quality risk management, supplier qualification, document control and management, data integrity, and internal and external audits.
**1. Key Responsibilities**
- Act as SME for QMS activities, i.e. change control, CAPA, deviation, quality risk management, supplier qualification, document control and management, data integrity internal and external audits and responsible for making quality decision related to these topics
- Lead the regulatory inspection preparation and see through the inspections from QMS perspective
- Develop and implement QMS SOPs/policies including but not limited to quality policies, quality manual, change control, CAPA, deviation, quality risk management, supplier qualification, document control and management, data integrity internal and external audits
- Review and approve all GMP documentations including but not limited to SOPs, change control, CAPA, deviation, risk assessment, supplier qualification, internal and external audits, batch records, validation/ qualification documents, sample/ test records
- Collaborate and work closely with all departments to improve quality culture
- Lead vendor qualification program and ensure compliance with regulatory requirements
- Review and approve material assessments, material qualification documentation and specifications of production raw material, excipient and disposables
- Develop and coordinate internal and external audits plans when necessary, and contribute to drafting the audit plan and report
- Support implementation of the process module of the Master Control project from the end user’s perspective, ensuring successful project deliverables meet the project schedule
- Support in equipment, facility, utility qualification, process, cleaning, analytical and microbial method validation activities
- Lead, coach and develop QA team members
- Perform other duties as required
**2. Knowledge, Skill and Experience**
- Bachelor’s Degree in Life Sciences or relevant field
- Minimum 6 years of experience in pharmaceutical or biopharmaceutical industry with minimum 1 year supervisory experience
- Strong quality mindset and quality decision making ability with holistic approach
- In depth knowledge of quality systems/quality assurance principles
- Knowledge and experience with aseptic processing is an advantage
- Excellent interpersonal skills and solid leadership skills
- Strong Knowledge of cGMP, US and EU regulatory requirements
- In-depth understanding of bulk manufacturing, aseptic filling process and biologic product characteristics
- Familiarity with in-process-control strategy and final product testing methods
- Experience working with inspectors and auditors from various regulatory bodies
- High proficiency in MS Word/Excel and has good writing skills
- Attention to detail
**WHY JOIN NBI?**
The best reason is because of our wonderful people and great work environment. If you are looking for a career with meaning and purpose, it’s hard to beat working in life sciences. We provide an attractive compensation and benefits package which recognizes people for their contributions, and comprehensive training and career development opportunities which support our employees’ growth with the company.
If you are interested in joining our team, we encourage you to APPLY today
